Medical Devices: FDA Has Met Most Performance Goals but Device Reviews Are Taking Longer: GAO-12-418 (Paperback) (ISBN-13: 9781287206958)

Even though FDA met all medical device performance goals for 510(k)s, the elapsed time from submission to final decision has increased substantially in recent years. This time to final decision includes the days FDA spends reviewing a submission as well as the days FDA spends waiting for a device sponsor to submit additional information in response to a request by the agency. FDA review time excludes this waiting time, and FDA review time alone is used to determine whether the agency met its performance goals. Each fiscal year since FY 2005 (the first year that 510(k) performance goals were in place), FDA has reviewed over 90 percent of 510(k) submissions within 90 days, thus meeting the first of two 510(k) performance goals. FDA also met the second goal for all 3 fiscal years it was in place by reviewing at least 98 percent of 510(k) submissions within 150 days. Although FDA has not yet completed reviewing all of the FY 2011 submissions, the agency was exceeding both of these performance goals for those submissions on which it had taken action. Although FDA review time decreased slightly from FY 2003 through FY 2010, the time that elapsed before FDA's final decision increased substantially. Specifically, from FY 2005 through FY 2010, the average time to final decision for 510(k)s increased 61 percent, from 100 days to 161 days.

Author: U. S. Government Accountability Office (
ISBN-10: 1287206956
ISBN-13: 9781287206958
Publisher: Bibliogov
Language: English
Published: 05/16/2013
Pages: 62
Format: Paperback
Weight: 0.28lbs
Size: 9.69h x 7.44w x 0.13d